MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC MICRO-INTRODUCER KIT; CATHETER

Model Number	7273V
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	12/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
One micro-introducer sheath was returned and evaluated, confirming the sheath hub was separated from the shaft.The mi kit sheath hub molding sub-assembly travelers were reviewed.The subassemblies used in the build for the reported finished good lot were manufactured prior to an implementation of changes per a previous internal corrective action.
Event or Problem Description
As reported: part of the sheath sheared off into patient and requires surgery.Additional information received via medwatch from site received 02jan20: left heart catheter procedure was aborted after sheath was dislodged from body after placement.The sheath required surgical removal and a right common femoral artery repair by vascular surgery.Patient was transferred to icu for stabilization and monitoring.Relevant tests/laboratory dates: nc myocardial perfusion (b)(6) 2019 other relevant history includes: elevated troponin, hypertension, chest pain, esrd on hemodialysis, coronary artery disease, a -fibrillation, sinus node dysfunction.

• Brand Name: MICRO-INTRODUCER KIT
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 9621926
• Report Number: 2134812-2020-00006
• Device Sequence Number: 503389
• Product Code: DYB
• UDI-Device Identifier: 10841156102982
• UDI-Public: (01)10841156102982
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180913
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 7273V
• Device Catalogue Number: 7273V
• Device Lot Number: 652666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 01/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 64 YR